Cervical Intraepithelial NeoplasiaNCT02934724
Impact of HPV Vaccine On The Prevalence Of HPV In Norway
An observational study of Cervical Intraepithelial Neoplasia and Cervical Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The overall aim of the study is to assess the effect of school-based Human Papillomavirus (HPV) vaccination by comparing type-specific HPV prevalence between vaccinated and non-vaccinated women born in 1997. Read more about this study
- Who is it for?
- Ages 18 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia, Cervical Cancer, Oropharyngeal Cancer
- What is being tested?
- Self sample from vagina, Self sample from the oral cavity and Questionnaire
- Type of treatment
- Vaccines, Pill or oral medicine, Surgery or procedure
- How many people
- 315 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2016to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 20 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women resident to Norway in 2009
Who may be able to join
- Female
- Born in 1997
- Resident of Norway in 2009
Who cannot join
- Male
- Born before or after 1997
- Non-resident of Norway in 2009
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of HPV Vaccine On The Prevalence Of Human Papillomavirus In Mouth And Vagina In Norway
The overall aim of the study is to assess the effect of school-based Human Papillomavirus (HPV) vaccination by comparing type-specific HPV prevalence between vaccinated and non-vaccinated women born in 1997. Women born in 1997, residence to Norway in 2009 (the year of vaccine initiation of the 1997-cohort) are invited to participate in the study.
Read the detailed description
This cohort is amongst the first that was offered HPV vaccine in an organized vaccination programme globally. The women will be recruited through Facebook ads. The study will enable us to measure differences in the prevalence of HPV types in vagina and the mouth between vaccinated and non-vaccinated young women in Norway.
The womens vaccination status will be validated by linkage to the Norwegian Immunisation Registry (SYSVAK) and their residence status will be validated through linkage to the Norwegian Population Registry.
- Being tested
- Self sample from vagina, Self sample from the oral cavity, Questionnaire
- Keywords
- HPV vaccines, HPV-6, HPV-11, HPV-16, HPV-18, Gardasil
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self sample from vaginaProcedure or surgery
Self sample using The Rover's Evalyn Brush
Self sample from the oral cavityProcedure or surgery
Self sample using COPAN FloqSwab
QuestionnaireOther
Questionnaire about vaccination status and sexual behaviour
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated | Women born in 1997, resident to Norway in 2009, vaccinated by the quadrivalent HPV vaccine.
Interventions:
* Self sample from vagina using Rover's Evalyn Brush
* Self sample from the oral cavity using COPAN's FloqSwab
* Questionnaire Receives: Procedure: Self sample from vagina; Procedure: Self sample from the oral cavity; Other: Questionnaire | |
| Un-vaccinated | Women born in 1997, resident to Norway in 2009, not vaccinated by the quadrivalent HPV vaccine
Interventions:
* Self sample from vagina using Rover's Evalyn Brush
* Self sample from the oral cavity using COPAN's FloqSwab
* Questionnaire Receives: Procedure: Self sample from vagina; Procedure: Self sample from the oral cavity; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal and oral HPV-6, HPV-11, HPV-16 and HPV-18 prevalence
The differences in HPV types prevalence among vaccinees and non-vaccinees. HPV types will be assessed individually and combined.
Measured: Within 2 months after self-collection of specimens
Secondary outcomes (1)
Description of oral and vaginal overall genotype distribution among vaccinated and non-vaccination participants
Measured: Within 2 months after self-collection of specimens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Akershus
- Responsible party
- Principal investigator, Espen Enerly, Oslo University Hospital
- Investigators
- Espen Enerly, Dr Scient, Principal investigator, Oslo University HospitalGiske Ursin, Dr.Med, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934724
- Sponsor's protocol ID
- 2014/2333
- Status last verified
- Dec 2020
- First submitted
- 13 Oct 2016
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
PLOS ONE Staff. Correction: An observational study comparing HPV prevalence and type distribution between HPV-vaccinated and -unvaccinated girls after introduction of school-based HPV vaccination in Norway. PLoS One. 2019 Dec 12;14(12):e0226706. doi: 10.1371/journal.pone.0226706. eCollection 2019.
PubMed 31830145Enerly E, Flingtorp R, Christiansen IK, Campbell S, Hansen M, Myklebust TA, Weiderpass E, Nygard M. An observational study comparing HPV prevalence and type distribution between HPV-vaccinated and -unvaccinated girls after introduction of school-based HPV vaccination in Norway. PLoS One. 2019 Oct 10;14(10):e0223612. doi: 10.1371/journal.pone.0223612. eCollection 2019.
PubMed 31600341
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of HPV Vaccine On The Prevalence Of Human Papillomavirus In Mouth And Vagina In Norway
- ClinicalTrials.gov ID
- NCT02934724
- Acronym / sponsor ID
- 2014/2333
- Keywords
- HPV vaccines, HPV-6, HPV-11, HPV-16, HPV-18, Gardasil
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Akershus
- Study start
- Nov 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of the study is to assess the effect of school-based Human Papillomavirus (HPV) vaccination by comparing type-specific HPV prevalence between vaccinated and non-vaccinated women born in 1997. Women born in 1997, residence to Norway in 2009 (the year of vaccine initiation of the 1997-cohort) are invited to participate in the study.
Detailed description
This cohort is amongst the first that was offered HPV vaccine in an organized vaccination programme globally. The women will be recruited through Facebook ads. The study will enable us to measure differences in the prevalence of HPV types in vagina and the mouth between vaccinated and non-vaccinated young women in Norway.
The womens vaccination status will be validated by linkage to the Norwegian Immunisation Registry (SYSVAK) and their residence status will be validated through linkage to the Norwegian Population Registry.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccinated | – | Procedure: Self sample from vagina, Procedure: Self sample from the oral cavity, Other: QuestionnaireWomen born in 1997, resident to Norway in 2009, vaccinated by the quadrivalent HPV vaccine. Interventions: * Self sample from vagina using Rover's Evalyn Brush * Self sample from the oral cavity using COPAN's FloqSwab * Questionnaire |
| Un-vaccinated | – | Procedure: Self sample from vagina, Procedure: Self sample from the oral cavity, Other: QuestionnaireWomen born in 1997, resident to Norway in 2009, not vaccinated by the quadrivalent HPV vaccine Interventions: * Self sample from vagina using Rover's Evalyn Brush * Self sample from the oral cavity using COPAN's FloqSwab * Questionnaire |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women resident to Norway in 2009
Key inclusion criteria (3 listed)
- Female
- Born in 1997
- Resident of Norway in 2009
Key exclusion criteria (3 listed)
- Male
- Born before or after 1997
- Non-resident of Norway in 2009
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self sample from vaginaSelf sample using The Rover's Evalyn Brush | Procedure or surgery | Un-vaccinated, Vaccinated |
| Self sample from the oral cavitySelf sample using COPAN FloqSwab | Procedure or surgery | Un-vaccinated, Vaccinated |
| QuestionnaireQuestionnaire about vaccination status and sexual behaviour | Other | Un-vaccinated, Vaccinated |
Primary outcome
Vaginal and oral HPV-6, HPV-11, HPV-16 and HPV-18 prevalence
Time frame: Within 2 months after self-collection of specimens
The differences in HPV types prevalence among vaccinees and non-vaccinees. HPV types will be assessed individually and combined.
1 secondary outcome
Description of oral and vaginal overall genotype distribution among vaccinated and non-vaccination participants
Time frame: Within 2 months after self-collection of specimens
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Background: PubMed 31830145PLOS ONE Staff. Correction: An observational study comparing HPV prevalence and type distribution between HPV-vaccinated and -unvaccinated girls after introduction of school-based HPV vaccination in Norway. PLoS One. 2019 Dec 12;14(12):e0226706. doi: 10.1371/journal.pone.0226706. eCollection 2019.
- Results publication: PubMed 31600341Enerly E, Flingtorp R, Christiansen IK, Campbell S, Hansen M, Myklebust TA, Weiderpass E, Nygard M. An observational study comparing HPV prevalence and type distribution between HPV-vaccinated and -unvaccinated girls after introduction of school-based HPV vaccination in Norway. PLoS One. 2019 Oct 10;14(10):e0223612. doi: 10.1371/journal.pone.0223612. eCollection 2019.
- Individual participant dataSharing planned: No
Related trials for Cervical Intraepithelial Neoplasia
RecruitingObservational study
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Cervical Cancer, Cervical Dysplasia
RecruitingObservational study
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Endometrial Cancer, Cervical Cancer
Recruiting
Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda
HIV (Human Immunodeficiency Virus), HPV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Espen Enerly, Dr Scient principal investigator
Oslo University Hospital
Giske Ursin, Dr.Med study director
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Intraepithelial Neoplasia and Cervical Cancer, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal and oral HPV-6, HPV-11, HPV-16 and HPV-18 prevalence (time frame: Within 2 months after self-collection of specimens). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02934724, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.